Observational Plan to Obtain Clinical Experience and Follow up Data on the Use of the ProxiFuse Hammer Toe Device

NCT02452671 | Terminated

• 1 other identifier: PTC-0156
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 5

Brief Summary

This is a multi-center, non-randomized, observational study to further evaluate the effectiveness and safety of the Proxifuse Hammer Toe Device when utilized for bone fixation. Approximately 4 US sites will participate. The primary endpoint will evaluate the 6 month post surgery change from baseline in the PROMIS Pain Interference computerized adaptive test (CAT) score.

Conditions

Toe Joint Deformity

Outcome Measures

Primary Outcomes (1)

• PROMIS Pain Interference computerized adaptive test (CAT) score

  Change from baseline at 6 months

Secondary Outcomes (4)

• PROMIS Pain Interference CAT scores

  Change from baseline at 2 weeks; 6 weeks and 3 months after surgery

• PROMIS Physical Functioning CAT scores

  Change from baseline at 2 weeks; 6 weeks; 3 months and 6 months after surgery

• Time to return to normal shoe wear

  Time recorded. Subjects will be queried at 2 weeks; 6 weeks; 3 months and 6 months and an actual date recorded. The number of days following surgery will be recorded for analysis

• Postoperative Adverse Events that require a return to the operating room

  From Operative time through 6 months

Other Outcomes (3)

• PROMIS Pain Intensity short form (SF)

  Patient reported outcomes at 2 weeks; 6 weeks ; 3 months and 6 months

• PROMIS Depression CAT

  Patient reported outcomes at 2 weeks; 6 weeks; 3 months and 6 months

• PROMIS Global Health

  Patient reported outcomes at 2 weeks; 6 weeks; 3 months and 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects who are candidates for hammer toe surgery.

You may qualify if:

• Greater than 18 years of age
• Has a hammertoe deformity causing daily pain and is a surgical candidate for hammertoe procedure in the 2nd, 3rd and/or 4th toe that has failed non-operative measures
• Capable of completing self-administered questionnaires
• Be willing and able to return for all study-related follow up procedures
• Has not participated in any other research protocol within the last 30 days and will not participate in any other research protocol during this study
• If female, is either using contraception or is postmenopausal, or male partner is using contraception
• Has been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the IRB

You may not qualify if:

• Active bacterial infection of the foot/feet to be treated
• Previous hammertoe correction that requires a revision to a toe to be treated under this study
• Patient is on chronic anticoagulation due to a bleeding disorder or has taken anticoagulants within 10 days prior to surgery
• Muscular imbalance, peripheral vascular disease that prohibits adequate healing, or a poor soft tissue envelope in the surgical field, absence of musculoligamentous supporting structures, or peripheral neuropathy
• Patient is not ambulatory or requires an additional surgical procedure that would prohibit the patient from following standard ProxiFuse post-operative recovery procedures
• Additional foot and ankle surgical procedures required during the index procedure other than foot procedures, lapidus and gastrocnemius recession
• Suspected or known allergic reaction to Nickel or Titanium metals
• Co-morbidity that reduces life expectancy to less than 12 months; or
• Patient is a prisoner or ward of the state

Sponsors & Collaborators

• Cartiva, Inc.: lead

Study Sites (5)

Stanford University

Redwood City, California, 94063, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Orthopaedic Associates of Michigan, PC

Grand Rapids, Michigan, 49525, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Study Officials

• Katie Strother

  Cartiva, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: May 22, 2015
• Study Start: June 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 22, 2017

Record last verified: 2016-07

Locations

US (5)